Federal Register / Vol. 76, No. 78 / Friday, April 22, 2011 / Notices 22711 

receiving a required plan of correction 

in accordance with the requirements at 

section 2728 of the SOM. 

B. Term of Approval 

Based on the review and observations 

described in section III of this final 

notice, we have determined that 

AAAASF’s requirements for 

organizations providing outpatient 

physical therapy and speech-language 

pathology services meet or exceed our 

requirements. Therefore, we approve 

AAAASF as a national accreditation 

organization for organizations that 

provide outpatient physical therapy and 

speech-language pathology services that 

request participation in the Medicare 

program, effective April 22, 2011 

through April 22, 2015. 

V. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 

(44 U.S.C. Chapter 35). 

In accordance with the provisions of 

Executive Order 12866, this notice was 

not reviewed by the Office of 

Management and Budget. 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program) 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: March 30, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2011–9176 Filed 4–21–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–2372–N] 

Announcement of the Re-Approval of 

the American Society of 

Histocompatibility and 

Immunogenetics (ASHI) as an 

Accreditation Organization Under the 

Clinical Laboratory Improvement 

Amendments of 1988 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

application of the American Society for 

Histocompatibility and Immunogenetics 

(ASHI) for re-approval as an 

accreditation organization for clinical 

laboratories under the Clinical 

Laboratory Improvement Amendments 

of 1988 (CLIA) program for the 

following specialty and subspecialty 

areas: General Immunology; 

Histocompatibility; and ABO/Rh typing. 

We have determined that the ASHI 

meets or exceeds the applicable CLIA 

requirements. We are announcing the 

re-approval and grant ASHI deeming 

authority for a period of 5 years. 

DATES: Effective Date: This notice is 

effective from April 22, 2011 to April 

22, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Penelope Meyers, (410) 786–3366. 

SUPPLEMENTARY INFORMATION: 

I. Background and Legislative 

Authority 

On October 31, 1988, the Congress 

enacted the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) (Pub. L. 100–578). CLIA 

amended section 353 of the Public 

Health Service Act. We issued a final 

rule implementing the accreditation 

provisions of CLIA on July 31, 1992 (57 

FR 33992). Under those provisions, 

CMS may grant deeming authority to an 

accreditation organization if its 

requirements for laboratories accredited 

under its program are equal to or more 

stringent than the applicable CLIA 

program requirements in 42 CFR part 

493 (Laboratory Requirements). Subpart 

E of part 493 (Accreditation by a Private, 

Nonprofit Accreditation Organization or 

Exemption Under an Approved State 

Laboratory Program) specifies the 

requirements an accreditation 

organization must meet to be approved 

by CMS as an accreditation organization 

under CLIA. 

II. Notice of Approval of the ASHI as 

an Accreditation Organization 

In this notice, we approve ASHI as an 

organization that may accredit 

laboratories for purposes of establishing 

its compliance with CLIA requirements 

for the subspecialty of General 

Immunology, the specialty of 

Histocompatibility, and the subspecialty 

of ABO/Rh typing. We have examined 

the initial ASHI application and all 

subsequent submissions to determine its 

accreditation program’s equivalency 

with the requirements for approval of an 

accreditation organization under 

subpart E of part 493. We have 

determined that the ASHI meets or 

exceeds the applicable CLIA 

requirements. We have also determined 

that the ASHI will ensure that its 

accredited laboratories will meet or 

exceed the applicable requirements in 

subparts H, I, J, K, M, Q, and the 

applicable sections of R. Therefore, we 

grant the ASHI approval as an 

accreditation organization under 

subpart E of part 493, for the period 

stated in the DATES section of this notice 

for the subspecialty of General 

Immunology, the specialty of 

Histocompatibility, and the subspecialty 

of ABO/Rh typing. As a result of this 

determination, any laboratory that is 

accredited by the ASHI during the time 

period stated in the DATES section of this 

notice will be deemed to meet the CLIA 

requirements for the listed 

subspecialties and specialties, and 

therefore, will generally not be subject 

to routine inspections by a State survey 

agency to determine its compliance with 

CLIA requirements. The accredited 

laboratory, however, is subject to 

validation and complaint investigation 

surveys performed by CMS, or its 

agent(s). 

III. Evaluation of the ASHI Commission 

Request for Approval as an 

Accreditation Organization Under 

CLIA 

The following describes the process 

used to determine that the ASHI 

accreditation program meets the 

necessary requirements to be approved 

by CMS and that, as such, CMS may 

approve ASHI as an accreditation 

program with deeming authority under 

the CLIA program. ASHI formally 

applied to CMS for approval as an 

accreditation organization under CLIA 

for the subspecialty of General 

Immunology, the specialty of 

Histocompatibility, and the subspecialty 

of ABO/Rh typing. In reviewing these 

materials, we reached the following 

determinations for each applicable part 

of the CLIA regulations: 

A. Subpart E—Accreditation by a 

Private, Nonprofit Accreditation 

Organization or Exemption Under an 

Approved State Laboratory Program 

The ASHI submitted its mechanism 

for monitoring compliance with all 

requirements equivalent to conditionlevel requirements, a list of all its 

current laboratories and the expiration 

date of their accreditation, and a 

detailed comparison of the individual 

accreditation requirements with the 

comparable condition-level 

requirements. The ASHI policies and 

procedures for oversight of laboratories 

performing laboratory testing for the 

subspecialty of General Immunology, 

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22712 Federal Register / Vol. 76, No. 78 / Friday, April 22, 2011 / Notices 

the specialty of Histocompatibility, and 

the subspecialty of ABO/Rh typing are 

equivalent to those of CLIA in the 

matters of inspection, monitoring 

proficiency testing (PT) performance, 

investigating complaints, and making 

PT information available. ASHI’s 

requirements for monitoring and 

inspecting laboratories are the same as 

those previously approved by CMS for 

laboratories in the areas of accreditation 

organization, data management, the 

inspection process, procedures for 

removal or withdrawal of accreditation, 

notification requirements, and 

accreditation organization resources. 

The requirements of the accreditation 

programs submitted for approval are 

equal to the requirements of the CLIA 

regulations. 

B. Subpart H—Participation in 

Proficiency Testing for Laboratories 

Performing Nonwaived Testing 

The ASHI’s requirements are equal to 

or more stringent than the CLIA 

requirements at § 493.801 through 

§ 493.865. 

For the specialty of 

Histocompatibility, ASHI requires 

participation in at least one external PT 

program, if available, in 

histocompatibility testing with an 80 

percent score required for successful 

participation and enhanced PT for 

laboratories that fail an event. The CLIA 

regulations do not contain a 

requirement for external PT for the 

specialty of Histocompatibility. For the 

subspecialty of General Immunology, 

and the subspecialty of ABO/Rh typing, 

ASHI’s requirements are equal to the 

CLIA requirements. 

C. Subpart J—Facility Administration 

for Nonwaived Testing 

The ASHI’s requirements for the 

submitted subspecialties and specialties 

are equal to the CLIA requirements at 

§ 493.1100 through § 493.1105. 

D. Subpart K—Quality System for 

Nonwaived Testing 

The ASHI requirements for the 

submitted subspecialties and specialties 

are equal to or more stringent than the 

CLIA requirements at § 493.1200 

through § 493.1299. For instance, 

ASHI’s control procedure requirements 

for the test procedures Nucleic Acid 

Testing and Flow Cytometry are more 

specific and detailed than the CLIA 

language for requirements for control 

procedures. Sections 493.1256(c)(1) and 

(c)(2) require control materials that will 

detect immediate errors and monitor 

accuracy and precision of test 

performance that may be caused by test 

system failures, environmental 

conditions and variance in operator 

performance. ASHI standards provide 

detailed, specific requirements for the 

control materials to be used to meet 

these CLIA requirements. 

E. Subpart M—Personnel for Nonwaived 

Testing 

We have determined that ASHI 

requirements for the submitted 

subspecialties and specialties are equal 

to or more stringent than the CLIA 

requirements at § 493.1403 through 

§ 493.1495 for laboratories that perform 

moderate and high complexity testing. 

Experience requirements for Director, 

Technical Supervisor, and General 

Supervisor exceed CLIA’s personnel 

experience requirements in the specialty 

of Histocompatibility. 

F. Subpart Q—Inspections 

We have determined that the ASHI 

requirements for the submitted 

subspecialties and specialties are equal 

to or more stringent than the CLIA 

requirements at § 493.1771 through 

§ 493.1780. The ASHI inspections are 

more frequent than CLIA requires. ASHI 

performs an onsite inspection every 2 

years and requires submission of a selfevaluation inspection in the intervening 

years. If the self-evaluation inspection 

indicates that an onsite inspection is 

warranted, ASHI conducts an additional 

onsite review. 

G. Subpart R—Enforcement Procedures 

The ASHI meets the requirements of 

subpart R to the extent that it applies to 

accreditation organizations. The ASHI 

policy sets forth the actions the 

organization takes when laboratories it 

accredits do not comply with its 

requirements and standards for 

accreditation. When appropriate, the 

ASHI will deny, suspend, or revoke 

accreditation in a laboratory accredited 

by the ASHI and report that action to us 

within 30 days. The ASHI also provides 

an appeals process for laboratories that 

have had accreditation denied, 

suspended, or revoked. 

We have determined that the ASHI’s 

laboratory enforcement and appeal 

policies are equal to or more stringent 

than the requirements of part 493 

subpart R as they apply to accreditation 

organizations. 

IV. Federal Validation Inspections and 

Continuing Oversight 

The Federal validation inspections of 

laboratories accredited by ASHI may be 

conducted on a representative sample 

basis or in response to substantial 

allegations of noncompliance (that is, 

complaint inspections). The outcome of 

those validation inspections, performed 

by CMS or our agents, or the State 

survey agencies, will be our principal 

means for verifying that the laboratories 

accredited by the ASHI remain in 

compliance with CLIA requirements. 

This Federal monitoring is an ongoing 

process. 

V. Removal of Approval as an 

Accrediting Organization 

Our regulations provide that we may 

rescind the approval of an accreditation 

organization, such as that of the ASHI, 

for cause, before the end of the effective 

date of approval. If we determine that 

the ASHI has failed to adopt, maintain 

and enforce requirements that are equal 

to, or more stringent than, the CLIA 

requirements, or that systemic problems 

exist in its monitoring, inspection or 

enforcement processes, we may impose 

a probationary period, not to exceed 1 

year, in which the ASHI would be 

allowed to address any identified issues. 

Should the ASHI be unable to address 

the identified issues within that 

timeframe, we may, in accordance with 

the applicable regulations, revoke 

ASHI’s deeming authority under CLIA. 

Should circumstances result in our 

withdrawal of the ASHI’s approval, we 

will publish a notice in the Federal 

Register explaining the basis for 

removing its approval. 

VI. Collection of Information 

Requirements 

This notice does not impose any 

information collection and record 

keeping requirements subject to the 

Paperwork Reduction Act (PRA). 

Consequently, it does not need to be 

reviewed by the Office of Management 

and Budget (OMB) under the authority 

of the PRA. The requirements associated 

with the accreditation process for 

clinical laboratories under the CLIA 

program, codified in 42 CFR part 493 

subpart E, are currently approved by 

OMB under OMB approval number 

0938–0686. 

VII. Executive Order 12866 Statement 

In accordance with the provisions of 

Executive Order 12866, this notice was 

not reviewed by the Office of 

Management and Budget. 

Authority: Section 353 of the Public 

Health Service Act (42 U.S.C. 263a). 

Dated: April 7, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2011–8948 Filed 4–21–11; 8:45 am] 

BILLING CODE 4120–01–P 

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